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ImmuPharma's license partner begins recruitment for Lupuzor trial for US FDA evaluation

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Specialist drug discovery and development company ImmuPharma (LON:IMM) has announced that Cephalon, its license partner for IPP-201101 Rigerimod (Lupozor), has started the recruitment of lupus patients for a Phase IIb trial in the US.

The study is designed to allow US based investigators and the FDA (Food and Drugs Administration) to evaluate its lead candidate for the treatment of lupus before commencing a Phase III clinical trial, the results pf which will be part of the package to be submitted to the FDA and other regulatory authorities for approval.

Cephalon has also entered into a separate sub-license agreement with Symbio Pharmaceuticals, retaining all commercialisation rights to Lupuzor in Japan, while Symbio is granted an exclusive right to conduct a Japanese-based Phase I clinical study which is mandatory for a future filing of the drug with the country’s regulatory bodies. The agreement is aimed at preparing for the commercial development of Lupuzor in Japan.

“We are extremely encouraged with the progress Cephalon is making with regards to the US trials, first steps into Japan and importantly their commitment to the Lupuzor programme,” said chief executive of ImmuPharma Dimitri Dimitriou.

ImmuPharma licensed Lupuzor to Cephalon last year for milestone payments that could reach US$500 million with US$45 million received so far, including US$15 million in Q4 and US$30 million in 2009. Final results of the Phase IIb study of the drug showed a clinically significant improvement in patient response rate versus placebo.

ImmuPharma is currently involved in the development of five drug candidates, which it claims have significant sales potential, for the treatment of: lupus; cancer; moderate to severe cancer pain or post-operative pain; highly resistant, hospital-acquired infections such as MRSA; and inflammatory and allergic disorders.

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Immupharma boss says Lupuzor trial recruitment “going well”

ImmuPharma PLC (LON:IMM) has begun dosing its first patients in the phase-III trial of its flagship drug Lupuzor for the hard-to-treat autoimmune disease Lupus. In all 200 people will take part in the study, which is being carried out over 10 centres in the States and 35 in Europe,...

on 05/04/2016

2 min read